Combining Chidamide with Decitabine and Camrelizumab for Hodgkin Lymphoma Patients
Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial
This study is testing if adding Chidamide to the current treatment of Decitabine and Camrelizumab can help people with Hodgkin Lymphoma who haven’t responded to other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Camrelizumab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04233294 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the effectiveness and safety of adding Chidamide to the existing treatment regimen of Decitabine and Camrelizumab for patients with relapsed or refractory Hodgkin Lymphoma. The study aims to provide a new therapeutic option for patients who have not responded to previous treatments. Participants will be closely monitored for treatment efficacy and safety outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 75 with histologically confirmed relapsed or refractory Hodgkin Lymphoma who have previously received Decitabine and Camrelizumab.
Not a fit: Patients with autoimmune diseases, serious uncontrolled medical disorders, or those who have had recent alimentary tract hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could offer a new hope for patients with resistant or relapsed Hodgkin Lymphoma.
How similar studies have performed: While there have been studies on Hodgkin Lymphoma treatments, the specific combination of Chidamide with Decitabine and Camrelizumab is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL). 2. 12 to 75 years of age. 3. ECOG performance of less than 2. 4. Life expectancy of at least 3 months. 5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6. Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. 7. Subjects must have adequate marrow, live, renal and heart functions. Exclusion Criteria: 1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month . 4. Prior organ allograft. 5. Women who are pregnant or breastfeeding. 6. Women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Where this trial is running
Beijing, Beijing
- Biotherapeutic Department of Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.